Ostomy appliance with integral closure

ABSTRACT

An ostomy pouch for both one and two-piece ostomy appliances having an integral closure at the bottom of the pouch to allow the pouch to be emptied and resealed without the use of a separate closure. The integral closure has mating male and female parts that are locked together either manually by finger pressure or by a sliding mechanism. The integral closure provides the ostomy appliance with a leakproof, odor-proof seal when in a closed, sealed, and locked position. A slider, when the appliance is closed, can be moved along the integral closure, thereby separating the mated male and female parts to provide an opening through which the stored contents within the ostomy pouch can be emptied. After the stored contents have been emptied, the slider can reseal the pouch by rejoining the male and female parts.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims the benefit of U.S. Provisional Application No.60/218,778, filed Jul. 18, 2000.

BACKGROUND OF THE INVENTION

An ostomy is a surgical operation in which the flow of either the colonor small intestine, hereinafter the intestine, of the patient,hereinafter referred to as the ostomate, is redirected from the normalpassageway and replaced with a portion of the intestine protruding froman orifice surgically formed in the abdomen. The portion of theintestine protruding from the surgically formed orifice is commonlyreferred to as a stoma in the medical community. The contents, i.e.,fecal matter, of the intestine are then involuntarily discharged throughthe surgically formed orifice and collected by an ostomy appliancepositioned over the stoma and attached to the abdomen of the ostomate.

An ostomy appliance conventionally includes a wafer and an ostomy pouch.The ostomy appliance may either be a one piece device or a two piecedevice, each of which includes a separate closure device to seal thebottom of the ostomy pouch. In the two piece device, the wafer isseparate from the ostomy pouch and attached to the body of the ostomate.With the one piece device, the wafer is integral with the ostomy pouch.Regardless of whether the wafer is separate from or integral with theostomy pouch, the wafer is positioned to be proximate the orificesurgically formed in the abdomen.

The wafer includes a flexible piece of synthetic material that adheresto the abdomen on a body side of the wafer and has an opening formednear the center thereof for the stoma to pass therethrough. The otherside of the wafer includes a locking ring designed to engage the ostomypouch, the locking ring encompassing the opening formed near the centerof the wafer.

The ostomy pouch is used to collect the fecal matter discharged from thestoma through the opening in the wafer. The pouch is known to be formedfrom a synthetic material, such as rubber or plastic, and comprises twowall panels joined together along the top and both sides. One of thewall panels, that is, the wall panel closest to the abdomen of theostomate, has an opening formed therein that also includes a lockingring configured to correspond to and lockingly mate with the lockingring of the wafer.

The opening and locking ring of the wall panel of the ostomy pouchclosest to the abdomen of the ostomate is placed around the stoma andeither attached directly to the body of the ostomate or to the wafer.The above-described arrangement results in the stoma being completelyenclosed and sealed by the ostomy pouch and wafer. When the ostomyappliance is applied correctly to the ostomate, the ostomy pouch andwafer, in conjunction with a closure, permit the stoma to be completelyenclosed, providing an air-tight, leak-proof, odor-proof seal. Theclosure is described in further detail below. In use, the ostomy pouchcollects the fecal matter discharged from the stoma. When necessary, theostomy pouch is then emptied of the collected contents.

Currently, there are two methods used by ostomates to empty the contentsof the ostomy pouch. The first method used by ostomates includes adisposable ostomy pouch, which requires the ostomate to simply remove,discard and replace the entire ostomy pouch with a clean and emptydisposable ostomy pouch. This type of ostomy pouch is commonly referredto as a non-drainable or single use device. Obviously, this method canbecome quite costly to the ostomate as well as the insurance provider,if there is one.

The second method, which is the more preferable and commonly used methodas it is more cost effective and convenient, is to discharge thecontents from the bottom of the open ended ostomy pouch. The opening isthen dosed via the separate closure and the ostomy pouch reused. Thistype of ostomy pouch is commonly referred to as a drainable or multi usedevice.

There are several well known manners for sealing the opening formed inthe bottom of the ostomy pouch. For example, U.S. Pat. Nos. 4,755,177and 5,125,133 disclose the use of a folding bar and clamp, respectively,to seal the bottom opening of the ostomy pouch after the contents havebeen emptied. Because the ostomy appliance is worn by the ostomates atall times of the day, whatever manner is used to seal the bottom openingof the ostomy pouch closed, it is imperative for health, safety, andquality of life reasons that the closure be secure and tight, so as topermit the normal twisting, turning, and other such active motionsperformed by individuals during typical daily life. As such, there mustbe zero, or very little, risk in the closure becoming separated orbroken, which would result in the unintentional release of the contentsin the ostomy pouch.

There have been several attempts to solve the above-described problem ofthe bottom opening of the ostomy pouch from unintentionally opening andprovide a secure, fluid and air-tight seal when normally dosed. However,each of the currently used closure techniques have particulardisadvantages. Such disadvantages include techniques that arecomplicated to perform, folding bars and clamps that are difficult andcostly to manufacture, the inability to properly seal the bottom openingof the ostomy pouch, the inability to of the ostomate to empty the fullostomy pouch without contacting the fecal matter contained therein, theinability of the ostomate to be comfortable enough to allow for normaldaily activities, the inability to properly use the ostomy pouch due tothe limited dexterity of the ostomates because of, for example, theiradvanced age, and danger of losing or dropping the clamp.

There are several drawbacks associated with the disposable ostomypouches. For example, it is fairly well established in the medicalcommunity that disposable ostomy pouches are feasible only withcolostomy ostomates because of the frequency of emptying the contents.In particular, while colostomy ostomates generally discard the pouchapproximately once a day, illeostomy ostomates empty the contents of thepouches on average 5 times, or more, per day. As such, illeostomyostomates have to replace the disposable pouches at least five times aday. Since ostomy pouches are costly, the use and disposal of severalpouches per day is economically impractical. Although the frequency ofcolostomy ostomates having to dispose such pouches is less thanilleostomy ostomates, even having to replace the pouches once a day canbecome costly. Additionally, unlike reusable ostomy pouches where onlythe contents are discarded, disposable pouches must be discarded in itsentirety, thus not permitting disposal in a toilet. Rather, thedisposable pouches, with the contents therein, must be disposed in asealed receptacle bin in order to avoid the offensive odors associatedwith such and maintain cleanliness. Moreover, ostomates that use thedisposable pouch encounter the problem of the replacement pouches notbeing compatible with the type of wafer already being used by theostomate, in addition to the inconvenience of having to carry severalreplacement pouches with them at all times.

As mentioned above, currently, the more popular manner of sealing thebottom opening of the ostomy pouch is the damp similar to that disclosedin U.S. Pat. No. 5,125,133. As briefly explained above, there areseveral drawbacks to using the clamp as well as the aforementionedfolding bar. For example, the United Ostomy Association has publishedreports indicating the average age of ostomates is 73 with 64% of allostomates being in the 65-90 age group. Put simply, a majority, butnowhere near all, of ostomates are elderly.

Therefore, the typical ostomate is very likely to have limiteddexterity. Typically, the use of a clamp requires the ostomate, to firstsit on the toilet, place the ostomy pouch between his or her legs, liftthe ostomy pouch with one hand so the contents are not placing pressureon the bottom opening that is sealed by the clamp, release the camp withthe other hand by pinching a small release mechanism on the clamp,separate the clamp closure, place the clamp on a separate surface whilestill holding the ostomy pouch with one hand, then slowly placing thenow unsealed ostomy pouch above an uncovered toilet, and release thecontents of the ostomy pouch. As if the above-detailed process is notlabor intensive enough, once the contents of the ostomy pouch have beendisposed of in the toilet, the ostomate must then dean the inside of theostomy pouch as thoroughly as possible. The bottom opening of the pouchmust then be sealed with the clamp while making sure the clamp isattached properly and securely, without dropping the damp in to thetoilet.

Consequently, the above-described method is extremely tedious,difficult, and extraordinarily risky for ostomates with limiteddexterity, let alone average dexterity. Therefore, the likelihood of thecontents being unintentionally evacuated prematurely, disposedincorrectly, or even have the damp fall into the toilet, along withnumerous other undesirable effects, is an everyday concern for everyostomate.

Another drawback with using the clamp or folding bar to seal the bottomopening of the ostomy pouch is that fecal matter may come in contact notonly with the inside lining of the pouch, but also, when emptying thecontents therein, with a portion of the exterior of the ostomy pouch.Additionally, when the ostomate is emptying the contents of the ostomypouch, since the fecal matter is evacuated through the bottom opening ofthe ostomy pouch, the entire opening is contaminated. Accordingly, anostomate must then properly clean each portion of the ostomy pouch,induding the opening, that has come in contact with the fecal matter.

Cleaning the contaminated portions of the ostomy pouch requires at thevery least a separate piece of toilet paper, or the like, to properlyclean the portion of the ostomy pouch. The damp or folding bar is thenplaced back on the bottom portion of the ostomy pouch, leaving a sectionof the bottom of the pouch that is to be folded up into the damp orfolding bar exposed. As the remaining portion has most likely beencontacted and thereby contaminated by the fecal matter, the ostomateneeds to dean, as well as possible, the lining at the bottom of theostomy pouch, the ostomate must endure the fact that the exposed lininghas most likely not been thoroughly cleaned, and the ostomate must alsoendure the lingering odors associated with the contents of the ostomypouch.

Yet another drawback to the damp is the lack of comfort it provides theostomate to enjoy routine daily activities. In particular, the clampscurrently being used are made of a hard, non-durable, synthetic plastic.Although the damp typically has a slight curved shape allegedly for thecomfort of the ostomate, the fact remains the hard plastic is extremelyuncomfortable, and poses several dangers when the ostomate engages inany sort of activity or recreational sport like walking jogging, and thelike. Since the hard plastic clamp is not fixedly attached to the bodyof the ostomate, the clamp moves around substantially during suchactivities and has been known to gouge the thigh or pelvic region of theostomate causing discomfort, and in extreme cases requiring medicalattention.

The clamps are also costly to manufacture. In other words, the use of aseparate component with the ostomy appliance, i.e., the damp or foldingbar, requires the manufacture of a separate piece besides the wafer andostomy pouch. Manufacturers require otherwise unnecessary machines,materials, and laborers, not to mention costs associated with researchand development, to make the clamps that are commonly provided toostomates at no charge.

U.S. Pat. No. 3,825,005 attempts to avoid the above-described drawbacksby providing a reusable pouch having the closure attached to the pouch.However, the reusable pouch does not successfully overcome the drawbacksassociated with complicated use, expensive manufacturing costs, andprovide a tight seal as is necessary to securely hold the fecal matter.The reusable pouch has several parts that are complicated to use,difficult to manufacture, and requires a similar method of use as withthe above-described clamp in terms of emptying the contents of thepouch.

Furthermore, the reusable pouch has several folds that require acomplicated method of sealing in light of the numerous components. Moreimportantly, the reusable pouch does not appear to overcome thecleanliness issue involved with emptying the reusable pouch, and ifanything appears to make cleaning of the interior of the pouch morecomplicated and difficult. Additionally, the method for closing thereusable pouch is not secure.

As such, currently there exists a need for a convenient, and costeffective ostomy appliance that overcomes all of the prior mentioneddrawbacks of known ostomy appliances.

SUMMARY OF THE INVENTION

It is an object of this invention to overcome the above-describeddrawbacks.

It is also an object of this invention to provide a clean, easy-to-use,cost efficient, secure, and unrestricting ostomy pouch having anintegral closure for ostomates.

It is yet another object of this invention to provide a reusable,resealable ostomy pouch that can be emptied without being detached fromthe abdomen of the ostomate, and without the need of a clamp, foldingbar, or other such securing device that is separate from the ostomypouch. The ostomy pouch of this invention includes a closure that isintegral with the ostomy pouch. The integral closure is a sealingmechanism that includes a male portion formed on a first wall panel ofthe ostomy pouch at the bottom opening and a female portion formed onthe second wall panel of the ostomy pouch at the bottom opening. Themale and female portions are configured to lockingly mate with eachother either by manual pressure, that is, finger pressure, or with aslider mechanism. The sliding mechanism joins the male and femaleportions so the bottom opening is closed to provide a secure seal.

These and other objects of the invention will be described in or beapparent from the following description of specific embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will be described in conjunction with the followingdrawings in which like reference numerals designate like elements andwherein:

FIG. 1 is a perspective view of a wafer used with the ostomy pouchaccording to an embodiment of this invention;

FIG. 2A is the ostomy pouch with the integral closure according to apreferred embodiment of this invention;

FIG. 2B is the ostomy pouch with the integral closure having the sealingmechanism according to an alternate embodiment of this invention;

FIG. 3 is a cross-sectional view of the ostomy pouch shown in FIGS. 2Aand 2B;

FIGS. 4A-4D are cross-section views of the different configurations ofthe male and female portions of the integral closure;

FIG. 5 is a schematic diagram illustrating how the slider matingly locksthe male and female portions of the integral closure; and

FIGS. 6A-6B illustrate the closed and opened states of the integralclosure.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

FIG. 1 is a perspective view of the wafer 10 used with the ostomy pouch20 according to this invention. The wafer 10 includes a skin layer 12and semi rigid disk 14 attached to the skin layer 12. The skin layer 12is made of a suitable flexible material and has an adhesive on the backside of the skin layer so that the wafer 10 adheres to the skin of theostomate. The disk 14 is disposed substantially in the center of theskin layer 12 and includes a locking ring 16 and a stoma opening 18. Thelocking ring 16 projects away from the skin layer 12 and disk 14 andlocks with a corresponding locking ring 26 on the ostomy pouch 20 aswill be explained in further detail below. Furthermore, the stomaopening 18 is configured to permit the stoma to pass therethrough.

Although the skin layer 12 is shown as being rectangular and the disk14, locking ring 16 and stoma opening 18 are shown as being circular inshape, respectively, it should be understood that the shown shapes aremerely for illustrative purposes and it is within the scope of thisinvention to have the components be any suitable geometric shape.

The ostomy pouch 20, as shown in FIGS. 2A-B, comprises first and secondwall panels 22 and 24 that are connected along the top and both sides ofthe pouch 20. The connected wall panels 22 and 24 form a storage area 23within which the contents expelled from the stoma are stored. See FIG.3. The ostomy pouch 20 also includes a locking ring 26 having an opening28 formed therein.

The locking ring 26 is designed to receive the locking ring 16 on thewafer 10 so that the wafer 10 and ostomy pouch 20 can be lockedtogether. In particular, the locking ring 26 may include an interiorraised edge 26 a and an exterior raised edge 26 b with a channel 26 cformed therebetween.

To secure the locking ring 16 of the wafer 10 in the locking ring 26 ofthe ostomy pouch 20, the locking ring 16 of the wafer 10 is positionedso the raised portion of the locking ring 16 snaps into the channel 26 cand is securely held therein by the interior and exterior edges 26 a and26 b. As such, the stoma opening 18 of the wafer 10 is in communicationwith the opening 28 of the ostomy pouch 20. Accordingly, the contents ofthe intestine, i.e., fecal matter, that are expelled by the stoma passthrough the stoma opening 18 and are conveyed to the storage area 23 ofthe ostomy pouch 20 where they are kept until the ostomate disposes ofsuch as will be explained in further detail below.

A bottom opening 29 (FIG. 6B) of the ostomy pouch 20 is formed by thewall panels 22 and 24 not being connected at the bottom portion of thepouch 20. The bottom opening 29 is sealed by a closure 30 that isintegral with the ostomy pouch 20. As shown in FIGS. 4A-4D, the wallpanel 22 at the bottom portion of the ostomy pouch 20 includes a firstportion 32, 42, 52, and 62, whereas the wall panel 24, also at thebottom portion of the ostomy pouch 20 and opposite the wall panel 22,includes a second portion 34, 44, 54, and 64. The first and secondportions 32, 42, 52, 62, and 34, 44, 54, 64, respectively, are formedfrom a material that is more rigid than the material from which the wallpanels 22 and 24 of the ostomy pouch 20 are formed. As such, when thefirst and second portions 34, 44, 54, 65 and 32, 42, 52, 62 are sealedtogether, the closures can withstand the pressure of the contents of theostomy pouch and not break the closure seal.

Furthermore, the first portions 32, 42, 52, 62 and second portions 34,44, 54, 64 each include male projections 33, 43, 53, and 63 andcorresponding female slots 35, 45, 55, and 65. The male projections 33,43, 53, and 63 and female slots 35, 45, 55, and 65 are alternatelyarranged along the first and second portions 32, 42, 52, 62 and 34, 44,54, and 64, respectively, from side to side so that the male projections33, 43, 53, and 63 can manually be pressed by the fingertips of theostomate into the female slots 35, 45, 55, and 65 as shown in FIGS.4A-4D.

FIGS. 4A-4D show the male projections 33, 43, 53, and 63 and thecorresponding female slots 35, 45, 55, and 65 as being trapezoidal,triangular, rectangular, and curvilinear in shape, respectively.However, the above-described and illustrated shapes are merely exemplaryand it is within the scope of this invention to have the maleprojections and female slots be any suitable geometric configuration.

Additionally, in an alternate embodiment of this invention, as shown inFIG. 26, the integral closure system may further include a slidermechanism 31 to facilitate sealing of the first and second portions 32,42, 52, 62 and 34, 44, 54, 64, respectively. As shown in FIG. 5, theslider mechanism 31 is configured to receive the first and secondportions 52 and 54 of the wall panels 22 and 24, respectively, of theostomy pouch 20. The rectangular shaped projections and slots 52 and 54are shown merely for example to provide an understanding of theoperation of the slider mechanism 31.

The slider mechanism 31 is generally rectangular in shape with anopening 60 formed in one side to receive the first and second portions52 and 52 of the wall panels 22 and 24, respectively. The slidermechanism 31 also includes pinching members 31 a and 31 b that form theopening 60 and apply pressure to the wall panels 22 and 24 of the ostomypouch 20 so as to apply pressure thereto and prevent the bottom opening29 of the ostomy pouch 20 from unintentionally releasing the contents inthe storage area 23.

Furthermore, the slider mechanism 31 includes a finger 32 extending intoan internal cavity of the slider mechanism 31. The cavity is configuredto receive the first and second portions 52 and 54 of the wall panels 22and 24, respectively. The finger 32 applies pressure to at least one ofthe first and second portions 52 and 54 so as to force the projections53 to matingly lock with the slots 55 to form an air-tight, odor freeseal.

As shown in FIG. 6A, when the slider mechanism is slid along the bottomof the ostomy pouch 20, the projections and slots 53 and 55 mate,thereby providing the desired seal and closes the ostomy pouch 20. Theslider mechanism, as well as the manual application of pressure to themating components, precludes the ostomate from the cumbersome andcomplicated techniques necessary in the prior art. Quite simply, asdescribed above, the ostomate merely needs to either manually applypressure to or slide the slider mechanism 31 along the bottom of thepouch 20 to close the bottom opening 29. To open the bottom opening 29to discard the stored contents, the ostomate merely opens the bottomopening 29 with their fingers or slides the slider mechanism 31 in thereverse direction and manually separates the mated first and secondportions. See FIG. 6B.

As such, the above-described ostomy appliance provides a reusable,resealable ostomy pouch having an integral closure that can be emptiedwithout being detached from the abdomen of the ostomate, and without theneed of a separate clamp, or separate securing device. The ostomyappliance of this invention is secure, easy to manufacture, convenient,clean, and easy-to-use. Furthermore, the ostomy appliance overcomes manyof the previously described drawbacks of the currently used devices andtechniques and does not require a substantial amount of dexterity on thepart of the ostomate. Additionally, because the closure is integral withthe ostomy pouch, the ostomate need not worry about the closing devicegauging the ostomate or otherwise seriously injuring the user or comingin contact with the fecal matter.

While the invention has been described in conjunction with specificembodiments thereof, it is evident that many alternatives, modificationsand variations may be apparent to those skilled in the art. Accordingly,the specific embodiments of the invention as set forth herein areintended to be illustrative, not limiting. As such, various changes maybe made without departing from the spirit and scope of the invention asset forth in the following claims.

What is claimed:
 1. An ostomy appliance that collects excreted human body waste, comprising: a wafer having a stoma opening through which the excreted human body waste passes; an ostomy pouch having first and second wall panels connected along a top edge and both side edges of the ostomy pouch to form a storage area therebetween, the first wall panel having an opening that communicates with the stoma opening, wherein the excreted human body waste passing through the stoma opening of the wafer is stored in the storage area, the first and second wall panels form a bottom opening at a bottom edge of the ostomy pouch through which the human body waste is disposed; and a closure integral with the bottom opening of the ostomy pouch and including a first portion of the first wall panel at the bottom opening of the ostomy pouch and a second portion of the second wall panel at the bottom opening of the ostomy pouch, wherein the first and second portions of the integral closure matingly engage each other to form an air-tight, odor-free seal that encloses the ostomy pouch with the human body waste being stored in the storage area, wherein the first and second portions are formed from a first material more rigid than a second material from which the first and second wall panels are formed, wherein the sealed integral closure withstands a pressure applied to the integral closure by the human body waste stored in the storage area, and wherein the first and second portions each include alternating and interlocking male projections and female slots.
 2. The ostomy appliance according to claim 1, wherein the alternating and interlocking male projections and female slots are trapezoidal in shape.
 3. The ostomy appliance according to claim 1, wherein the alternating and interlocking male projections and female slots are triangular in shape.
 4. The ostomy appliance according to claim 1, wherein the alternating and interlocking male projections and female slots are rectangular in shape.
 5. The ostomy appliance according to claim 1, wherein the alternating and interlocking male projections and female slots are curvilinear in shape.
 6. The ostomy appliance according to claim 1, wherein the wafer and ostomy pouch are integrated to form a one piece appliance.
 7. The ostomy appliance according to claim 1, further comprising a slider that receives and substantially encompasses the first and second portions of the integral closure.
 8. The ostomy appliance according to claim 7, wherein the slider comprises an internal cavity and first and second pinching members that form an opening through which the ostomy pouch is received and apply a pressure to the first and second wall panels to prevent the bottom opening from opening and unintentionally releasing the stored human body waste.
 9. The ostomy appliance according to claim 8, wherein the slider further comprises a finger extending inward into the internal cavity, wherein the finger applies pressure to at least one of the first and second portions to force the male projections to matingly interlock with the female slots.
 10. An ostomy appliance that collects excreted human body waste, comprising: a wafer having a stoma opening through which the excreted human body waste passes; an ostomy pouch having first and second wall panels connected along a top edge and both side edges of the ostomy pouch to form a storage area therebetween, the first wall panel having an opening that communicates with the stoma opening, wherein the excreted human body waste passing through the stoma opening of the wafer is stored in the storage area, the first and second wall panels form a bottom opening at a bottom edge of the ostomy pouch through which the human body waste is disposed; a closure integral with the bottom opening of the ostomy pouch and including a first portion of the first wall panel at the bottom opening of the ostomy pouch and a second portion of the second wall panel at the bottom opening of the ostomy pouch, wherein the first and second portions of the integral closure matingly engage each other to form an air-tight, odor-free seal that encloses the ostomy pouch with the human body waste being stored in the storage area; and a slider that receives and substantially encompasses the first and second portions of the integral closure, wherein the slider comprises an internal cavity and first and second pinching members that form an opening through which the ostomy pouch is received and apply a pressure to the first and second wall panels to prevent the bottom opening from opening and unintentionally releasing the stored human body waste, wherein the first and second portions are formed from a first material more rigid than a second material from which the first and second wall panels are formed, wherein the sealed integral closure withstands a pressure applied to the integral closure by the human body waste stored in the storage area, and wherein the first and second portions each include alternating and interlocking male projections and female slots.
 11. The ostomy appliance according to claim 10, wherein the alternating and interlocking male projections and female slots are trapezoidal in shape.
 12. The ostomy appliance according to claim 10, wherein the alternating and interlocking male projections and female slots are triangular in shape.
 13. The ostomy appliance according to claim 10, wherein the alternating and interlocking male projections and female slots are rectangular in shape.
 14. The ostomy appliance according to claim 10, wherein the alternating and interlocking male projections and female slots are curvilinear in shape.
 15. The ostomy appliance according to claim 10, wherein the wafer and ostomy pouch are integrated to form a one piece appliance.
 16. The ostomy appliance according to claim 10, wherein the slider further comprises a finger extending inward into the internal cavity, wherein the finger applies pressure to at least one of the first and second portions to force the male projections to matingly interlock with the female slots. 